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Trial registered on ANZCTR


Registration number
ACTRN12619000197134
Ethics application status
Approved
Date submitted
7/02/2019
Date registered
12/02/2019
Date last updated
17/10/2019
Date data sharing statement initially provided
12/02/2019
Date results information initially provided
17/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study of the gas flow delivered by bubble continuous positive airway pressure (CPAP) to preterm infants in neonatal intensive care
Scientific title
An observational study of the gas flow delivered by bubble CPAP to preterm infants in neonatal intensive care
Secondary ID [1] 297314 0
None
Universal Trial Number (UTN)
U1111-1228-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome 311421 0
Condition category
Condition code
Respiratory 310051 310051 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 310052 310052 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Preterm infants receiving bubble CPAP in the neonatal intensive care unit will have demographic information and weight recorded. The current state of the infant including flow rate, bCPAP pressure, mouth opening, and nasal prong fit will be recorded. The gas flow will then be adjusted until bubbling just ceases and the flow and pressure measurements will be repeated. The infant’s chin will then be gently supported to close the mouth, and the measurements taken for a third time. This will be recorded for 50 infants over the space of 3 months. It will take approximately 15 minutes to record each neonate.
Intervention code [1] 313568 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318951 0
Gas flow in litres per minute delivered by bubble CPAP at a range of set pressures to the nose of preterm infants.
CPAP pressure will be monitored via a pressure monitor connected to the inspiratory limb of the system. Gas flow to the infant will be read from the flow meter in L/min once bubbling has ceased in the bubble chamber.
Timepoint [1] 318951 0
At time of observation.
Secondary outcome [1] 366521 0
Gas flow changes in litres per minute with mouth opened or closed.
Gas flow to the infant will be read from the flow meter in L/min once bubbling has ceased in the bubble chamber. Mouth opening will be assessed as either open or closed by observation.
Timepoint [1] 366521 0
At time of observation.

Eligibility
Key inclusion criteria
- Infants born less than 37 weeks gestation.
- Currently receiving bubble CPAP therapy for any reason in the neonatal intensive care unit (NICU).
- Agreement from the treating clinician to include the infant in the study.
- Informed consent for participation in the study provided by the parent or guardian.
Minimum age
No limit
Maximum age
6 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Informed consent refused or withdrawn by a parent or guardian.
- Unstable clinical condition, including but not limited to respiratory distress and varying oxygen saturation.
- Deemed unsuitable by the treating clinician for participation in the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
A convenience sample of 50 babies will be enrolled to the study. This provides 80% power to detect a 0.4 standard deviation difference between pressures of 5 and 8 mmH2O.

For the primary outcome, the data will be presented as the mean and standard deviations or median with interquartile range depending on the normality of the data. For the primary outcome only the first assessment will be used. A secondary analysis using all measurements from individual infants will be undertaken.

The effect of infant weight on the delivered flow will be determined by comparing mean (SD) flow of infants <1000g, 1000-1499g, 1500-2499g using ANOVA.
The effect of mouth closure will be determined using a paired t-test.

Demographic data will be descriptive and will be reported as means (standard deviations), medians (interquartile ranges), or proportions as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13051 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 25557 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 301878 0
Hospital
Name [1] 301878 0
Department of Newborn Research, The Royal Women's Hospital, Melbourne
Address [1] 301878 0
Level7,
20 Flemington Road
PARKVILLE VIC 3052
Country [1] 301878 0
Australia
Primary sponsor type
Hospital
Name
Department of Newborn Research, The Royal Women's Hospital Melbourne
Address
Level 7,
20 Flemington Road
PARKVILLE VIC 3052
Country
Australia
Secondary sponsor category [1] 301631 0
None
Name [1] 301631 0
Address [1] 301631 0
Country [1] 301631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302569 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 302569 0
20 Flemington Road
PARKVILLE VIC 3052
Ethics committee country [1] 302569 0
Australia
Date submitted for ethics approval [1] 302569 0
16/01/2019
Approval date [1] 302569 0
19/03/2019
Ethics approval number [1] 302569 0

Summary
Brief summary
This is a single-centre observational study that aims to measure the gas flow delivered by bubble CPAP to preterm infants in neonatal intensive care. The project will aim to recruit 50 stable infants currently receiving bubble CPAP in the Royal Women’s Hospital Neonatal Intensive Care Unit. The data collection process involves: recording of the gas flow and pressure of the bubble CPAP apparatus at baseline; decreasing the gas flow until bubbling ceases whilst maintaining the CPAP pressure to record the gas flow being delivered to the infant; recording the gas flow with the infant’s mouth closed; after which the gas flow will be returned to its initial setting. This information will provide insight into the mechanism of action of bubble CPAP compared to other non-invasive respiratory supports such as Nasal High-flow Therapy (nHFT). We hypothesise that the gas flow produced in bubble CPAP is similar to that used in nHFT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90690 0
Mr Cameron Payne
Address 90690 0
Newborn Research Centre, The Royal Women's Hospital, Melbourne
Level 7,
20 Flemington road
PARKVILLE VICTORIA 3052
Country 90690 0
Australia
Phone 90690 0
+61 3 84353763
Fax 90690 0
Email 90690 0
cpayne1@student.unimelb.edu.au
Contact person for public queries
Name 90691 0
Mr Cameron Payne
Address 90691 0
Newborn Research Centre, The Royal Women's Hospital, Melbourne
Level 7,
20 Flemington road
PARKVILLE VICTORIA 3052
Country 90691 0
Australia
Phone 90691 0
+61 3 84353763
Fax 90691 0
Email 90691 0
cpayne1@student.unimelb.edu.au
Contact person for scientific queries
Name 90692 0
Mr Cameron Payne
Address 90692 0
Newborn Research Centre, The Royal Women's Hospital, Melbourne
Level 7,
20 Flemington road
PARKVILLE VICTORIA 3052
Country 90692 0
Australia
Phone 90692 0
+61 3 84353763
Fax 90692 0
Email 90692 0
cpayne1@student.unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data collected in this study will be used only for the purposes of this study. Pooled, de-identified results will also be published as a part of the study.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary